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National Pharmaceutical Pricing Authority (NPPA) is an organization of the Government of India which is an executive body under the Drugs (Prices Control) Order (DPCO), 2013 established to fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country. There are some key announcements/notice released by NPPA for the month of December 2017 as described below -
On December 06, 2017, NPPA released the list of formulations pending for ceiling price fixations as on November 2017 under NLEM 2015, as the All Indian Origin Chemists & Distributors (AIOCD) association's Pharmatrac is not capturing the Price to Retailer (PTR) and Moving Annual Turnover (MAT) of said formulations. Therefore, NPPA requested all the concerned manufacturers / marketing companies to furnish the PTR & MAT in terms of value, duly self-attested with proper authorized signature & seal of the authorized officer of the company, for the formulations listed in NLEM, 2015 (revised Schedule - I of DPCO, 2013) i.e. Annexure -I for the month of August 2015 by December 22, 2017 for enabling NPPA to take appropriate action for ceiling price fixation under provisions of DPCO, 201327.
On December 18, 2017, the NPPA has fixed/revised the ceiling /retail prices of 65 scheduled formulations under DPCO. The 65 scheduled formulations under price cap are mostly from anti-cancer, anti-HIV, anti-diabetics, lipid lowering drugs and other antibiotics categories as described below under various provisions -
Table1-Notified Retail price of 63 formulations under Drugs (Prices Control) Order, 2013
Table 2 - Notified Retail price of 1 scheduled formulation of Schedule-I under Drugs (Prices Control) Order, 2013.
Table 3 - Notified ceiling price of 1 scheduled formulation of Schedule-I under para 19 of Drugs (Prices Control) Order, 2013.
On December 19, 2017, the NPPA has decided to de-link the price approval of new drugs with its internal guidelines. Earlier, in September 2014, the drug pricing regulator had asked all pharmaceutical firms to register themselves under its Integrated Pharmaceutical Database Management System (IPDMS), making this a requirement for fixing and revising drug prices. Now, NPPA in an office memorandum, has said that"price approval not be linked to IPDMS and any other conditionality"28.
On December 20, 2017, the NPPA has fixed/revised the retail prices of 27 scheduled formulations under DPCO, 2013; the formulations with price caps are mostly from anti-diabetics, anti-hypertensive including other antibiotics categories as described below under various provisions –
Table 4 - Notified Retail price of 12 formulations under Drugs (Prices Control) Order, 2013
Table 5 - Notified Retail Price of 15 formulations under Drugs (Prices Control) Order, 2013
On December 27, 2017, the NPPA has considered the request of M/s India Medtronic Pvt. Ltd for discontinuation of Endeavor Sprint RX Zotarolimus Eluting Coronary Stent based on unavailability because of stoppage of its production globally; and noted in the Authority meeting No 51 held on 15/12/2017. The consideration was under para 21(2) of Drugs Prices Control Order (DPCO), 2013 on the ground of stoppage of manufacturing of these stent brands globally.
Para 21 (2) of the DPCO, 2013 reads as follows:
21. Monitoring the availability of scheduled formulations:
(2) Any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the government in Form- IV of Schedule-ll of this order in this regard at least six months prior to the indented date of discontinuation and the Government may, in public interest, direct the manufacturer of the scheduled formulation to continue with required level of production or import for the period not exceeding one year, from the intended date of such discontinuation within a period of sixty days of receipt of such intimation
NPPA has further advised that, in order to formally 'complete' the process of 'withdrawal' the company will issue a public notice in the prescribed format, in at least two national newspapers (one English and one in Hindi) and also publish the same on their website and send a copy of the same to NPPA29.
27 http://www.nppaindia.nic.in/order/om_07-12-2017.pdf
28 http://www.nppaindia.nic.in/order/om_19-12-2017.pdf
29 http://www.nppaindia.nic.in/order/om_27-12-2017.pdf
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